Surgery (St Vincent's) - Research Publications
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ItemLaying the foundations of community engagement in Aboriginal health research: establishing a community reference group and terms of reference in a novel research field.(Springer Science and Business Media LLC, 2022-08-04)BACKGROUND: Community engagement or community involvement in Aboriginal health research is a process that involves partnering, collaborating and involving Aboriginal and Torres Strait Islander people or potential research participants to empower them to have a say in how research with Aboriginal communities is conducted. In the context of Aboriginal health, this is particularly important so that researchers can respond to the priorities of the community under study and conduct research in a way that is respectful of Aboriginal cultural values and beliefs. One approach to incorporating the principals of community engagement and to ensure cultural oversight and guidance to projects is to engage a community reference group. The aim of this study was to describe the process of establishing an Aboriginal community reference group and terms of reference. The community reference group was established to guide the research activities of a newly formed research collaboration aiming to to develop osteoarthritis care that meets the needs of Aboriginal and Torres Strait Islander people in Australia. METHODS: Adopting a Participatory Action Research approach, this two-phase study was conducted in Victoria, Australia. In phase one, semi-structured research yarns (a cultural form of conversation used as a data gathering tool) were conducted collaboratively by Aboriginal and non-Aboriginal co-investigators to explore Aboriginal health stakeholder perspectives on establishing a community reference group and terms of reference. In phase two, recommendations in phase one were identified to invite members to participate in the community reference group and to ratify the terms of reference through a focus group. Data were analyzed using a framework analysis approach. RESULTS: Thirteen people (eight female, four male) participated in phase one. Participants represented diverse professional backgrounds including physiotherapy, nursing, general practice, health services management, hospital liaison, cultural safety education, health research and the arts. Three themes were identified in phase one; Recruitment and Representation (trust and relationships, in-house call-outs, broad-spectrum expertise and Aboriginal majority); Purpose (community engagement, research steering, knowledge dissemination and advocacy) and; Function and Logistics (frequency and format of meetings, size of group, roles and responsibilities, authority, communication and dissemination). In phase two, six Aboriginal people were invited to become members of the community reference group who recommended changes which were incorporated into the seven domains of the terms of reference. CONCLUSION: The findings of this study are captured in a 10-step framework which describes practical strategies for establishing a community reference group and terms of reference in Aboriginal health research.
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ItemPatient and clinician characteristics and preferences for increasing participation in placebo surgery trials: a scoping review of attributes to inform a discrete choice experiment(BMC, 2022-04-12)BACKGROUND: Orthopaedic surgeries include some of the highest volume surgical interventions globally; however, studies have shown that a significant proportion of patients report no clinically meaningful improvement in pain or function after certain procedures. As a result, there is increasing interest in conducting randomised placebo-controlled trials in orthopaedic surgery. However, these frequently fail to reach recruitment targets suggesting a need to improve trial design to encourage participation. The objective of this study was to systematically scope the available evidence on patient and clinician values and preferences which may influence the decision to participate in placebo surgery trial. METHODS: A systematic review was conducted via a literature search in the MEDLINE, Embase, PsycInfo, CINAHL, and EconLit databases as of 19 July 2021, for studies of any design (except commentaries or opinion pieces) based on two key concepts: patient and clinician characteristics, values and preferences, and placebo surgery trials. RESULTS: Of 3424 initial articles, we retained 18 eligible studies. Characteristics, preferences, values, and attitudes of patients (including levels of pain/function, risk/benefit perception, and altruism) and of clinicians (including concerns regarding patient deception associated with placebo, and experience/training in research) influenced their decisions to participate in placebo-controlled trials. Furthermore, some aspects of trial design, including randomisation procedures, availability of the procedure outside of the trial, and the information and consent procedures used, also influenced decisions to participate. CONCLUSION: Participant recruitment is a significant challenge in placebo surgery trials, and individual decisions to participate appear to be sensitive to preferences around treatment. Understanding and quantifying the role patient and clinician preferences may play in surgical trials may contribute to the optimisation of the design and implementation of clinical trials in surgery.
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ItemEvaluating willingness for surgery using the SMART Choice (Knee) patient prognostic tool for total knee arthroplasty: study protocol for a pragmatic randomised controlled trial(BMC, 2022-02-24)BACKGROUND: Approximately 1 in 5 patients feel unsatisfied after total knee arthroplasty (TKA). Prognostic tools may aid in the patient selection process and reduce the proportion of patients who experience unsatisfactory surgery. This study uses the prognostic tool SMART Choice (Patient Prognostic Tool for Total Knee Arthroplasty) to predict patient improvement after TKA. The tool aims to be used by the patient without clinician input and does not require clinical data such as X-ray findings or blood results. The objective of this study is to evaluate the SMART Choice tool on patient decision making, particularly willingness for surgery. We hypothesise that the use of the SMART Choice tool will influence willingness to undergo surgery, especially when used earlier in the patient TKA journey. METHODS: This is a multicentred, pragmatic, randomised controlled trial conducted in Melbourne, Australia. Participants will be recruited from the St. Vincent's Hospital, Melbourne (SVHM) Orthopaedic Clinic, and the client base of HCF, Australia (private health insurance company). Patients over 45 years of age who have been diagnosed with knee osteoarthritis and considering TKA are eligible for participation. Participants will be randomised to either use the SMART Choice tool or treatment as usual. The SMART Choice tool provides users with a prediction for improvement or deterioration / no change after surgery based on utility score change calculated from the Veterans-RAND 12 (VR-12) survey. The primary outcome of the study is patient willingness for TKA surgery. The secondary outcomes include evaluating the optimal timing for tool use and using decision quality questionnaires to understand the patient experience when using the tool. Participants will be followed up for 6 months from the time of recruitment. DISCUSSION: The SMART Choice tool has the potential to improve patient decision making for TKA. Although many prognostic tools have been developed for other areas of surgery, most are confined within academic bodies of work. This study will be one of the first to evaluate the impact of a prognostic tool on patient decision making using a prospective clinical trial, an important step in transitioning the tool for use in clinical practice. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12622000072718 . Prospectively registered - 21 January 2022.
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ItemAddressing surgical inequity for Aboriginal and Torres Strait Islander people in Australia's universal health care system: a call to action(WILEY, 2021-01-28)Aboriginal and Torres Strait Islander people continue to experience health inequity within the Australian health care system. Little research has examined how disparities in surgical care access and outcomes contribute to Aboriginal health. In this narrative review and call to action, we discuss five care points along the journey to high-quality surgical care: health care seeking, primary health care services, specialist services, surgery and surgical outcomes. We highlight barriers and disparities that exist along this journey, drawing examples from the field of joint replacement surgery. Finally, we present opportunities for change at the health system, health service and clinician level, calling upon researchers, clinicians and policy makers to confront the surgical disparities experienced by Aboriginal and Torres Strait Islander people.
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ItemSham surgery: justified but practical? A systematic review of sham surgery trials in orthopaedics(Academy of Science of South Africa, 2018)BACKGROUND: An increasing trend for sham surgery trials in minor orthopaedic procedures has been observed. Trial outcomes have changed the practice landscape of these procedures. However, there has been no sham surgery trial in a major orthopaedic procedure. The aims of this systematic review were to consider the ethics of sham surgery trials; to describe orthopaedic sham surgery trials conducted to date; and to consider the challenges that will need to be overcome in order to conduct sham surgery trials for major orthopaedic procedures in the future. METHODS: A systematic review of the literature and clinical trial registries was undertaken. Trials with a published main findings paper underwent a risk of bias assessment using the Cochrane Collaboration risk of bias tool, in addition to an ethical assessment based on the work of Horng and Miller. RESULTS: We identified 22 sham surgery trials for minor orthopaedic procedures that have been completed, terminated, or are currently in process. Among the ten trials with a published main findings paper, only one was free from risk of bias; all others were at risk of bias. According to the ethical assessment, the benefits of a sham control were outweighed by the risks in all but two of the ten trials. Across the 22 trials with published and unpublished main findings, participant recruitment within reasonable timeframes, as well as the low threshold for crossover from the sham were recurring challenges. CONCLUSIONS: Researchers are obliged to carefully consider the feasibility of conducting a sham surgery trial in a major orthopaedic procedure, before drawing on limited research funds. Exploring the conditions under which patients and surgeons would find participation in a sham surgery trial acceptable, and simulating trial costs based on patient and surgeon preferences may assist funders, assessors and ethics boards to determine whether to support the conducting of future sham surgery trials in major orthopaedic procedures.
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ItemMisconceptions and the Acceptance of Evidence-based Nonsurgical Interventions for Knee Osteoarthritis. A Qualitative Study(LIPPINCOTT WILLIAMS & WILKINS, 2019-09-01)BACKGROUND: In contrast to best practice guidelines for knee osteoarthritis (OA), findings from several different healthcare settings have identified that nonsurgical treatments are underused and TKA is overused. Empirical evidence and qualitative observations suggest that patients' willingness to accept nonsurgical interventions for knee OA is low. A qualitative investigation of why patients may feel that such interventions are of little value may be an important step toward increasing their use in the treatment of knee OA QUESTIONS/PURPOSES: This qualitative study was embedded in a larger study investigating patient-related factors (beliefs/attitudes toward knee OA and its treatment) and health-system related factors (access, referral pathways) known to influence patients' decisions to seek medical care. In this paper we focus on the patient-related factors with the aim of exploring why patients may feel that nonsurgical interventions are of little value in the treatment of knee OA. METHODS: A cross-sectional qualitative study was conducted in a single tertiary hospital in Australia. Patients with endstage knee OA on the waiting list for TKA were approached during their preadmission appointment and invited to participate in one-to-one interviews. As prescribed by the qualitative approach, data collection and data analysis were performed in parallel and recruitment continued until the authors agreed that the themes identified would not change through interviews with subsequent participants, at which point, recruitment stopped. Thirty-seven patients were approached and 27 participated. Participants were 48% female; mean age was 67 years. Participants' beliefs about knee OA and its treatment were identified in the interview transcripts. Beliefs were grouped into five belief dimensions: identity beliefs (what knee OA is), causal beliefs (what causes knee OA), consequence beliefs (what the consequences of knee OA are), timeline beliefs (how long knee OA lasts) and treatment beliefs (how knee OA can be controlled). RESULTS: All participants believed that their knee OA was "bone on bone" (identity beliefs) and most (> 14 participants) believed it was caused by "wear and tear" (causal beliefs). Most (> 14 participants) believed that loading the knee could further damage their "vulnerable" joint (consequence beliefs) and all believed that their pain would deteriorate over time (timeline beliefs). Many (>20 participants) believed that physiotherapy and exercise interventions would increase pain and could not replace lost knee cartilage. They preferred experimental and surgical treatments which they believed would replace lost cartilage and cure their knee pain (treatment beliefs). CONCLUSIONS: Common misconceptions about knee OA appear to influence patients' acceptance of nonsurgical, evidence-based treatments such as exercise and weight loss. Once the participants in this study had been "diagnosed" with "bone-on-bone" changes, many disregarded exercise-based interventions which they believed would damage their joint, in favor of alternative and experimental treatments, which they believed would regenerate lost knee cartilage. Future research involving larger, more representative samples are needed to understand how widespread these beliefs are and if/how they influence treatment decisions. In the meantime, clinicians seeking to encourage acceptance of nonsurgical interventions may consider exploring and targeting misconceptions that patients hold about the identity, causes, consequences, timeline, and treatment of knee OA. LEVEL OF EVIDENCE: Level II, prognostic study.
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ItemWhat Influences Patient Satisfaction after TKA? A Qualitative Investigation(LIPPINCOTT WILLIAMS & WILKINS, 2020-08-01)BACKGROUND: Patient satisfaction is a common measure of the success of an orthopaedic intervention. However, there is poor understanding of what satisfaction means to patients or what influences it. QUESTIONS/PURPOSES: Using qualitative study methodology in patients undergoing TKA, we asked: (1) What does it mean to be satisfied after TKA? (2) What factors influence satisfaction levels after TKA? METHODS: People in a hospital registry who had completed 12-month follow-up questionnaires and were not more than 18 months post-TKA at the time of sampling were eligible (n = 121). To recruit a sample that provided insight into a range of TKA experiences, we divided eligible candidates on the registry into quadrants based on their responder status and satisfaction level. A responder was an individual who experienced a clinically meaningful change in pain and/or function on the WOMAC according to the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responder criteria. Individuals were considered satisfied unless they indicated somewhat dissatisfied or very dissatisfied for one or more of the four items on the Self-Administered Patient Satisfaction Scale. From the resulting quadrants: responder satisfied, nonresponder satisfied, nonresponder dissatisfied, responder dissatisfied, we identified men and women with a range of ages and invited them to participate (n = 85). The final sample (n = 40), consisted of 10 responder satisfied, nine nonresponder satisfied, eight nonresponder dissatisfied, and 13 responder dissatisfied; 71% were women, with a mean age of 71 ± 7 years and a mean time since TKA surgery of 17 ± 2 months (range 13 to 25 months). Interview transcripts were analyzed by looking for factors in the participants' narrative that appeared to underscore their level of satisfaction and attaching inductive (data-derived, rather than a priori derived) codes to relevant sections of text. Coded data from participants who reported high and low levels of satisfaction were compared/contrasted and emerging patterns were mapped into a conceptual model. Recruitment continued until no new information was uncovered in data analysis of subsequent interviews, signalling to the researchers that further interviews would not change the key themes identified and data collection could cease. RESULTS: In those with high satisfaction levels, satisfaction was conceptualized as an improvement in pain and function. In those with low satisfaction levels, rather than an improvement, satisfaction was conceptualized as completely resolving all symptoms and functional limitations. In addition, we identified three pathways through which participants reached different levels of low and high satisfaction: (1) The full-glass pathway, characterized by no or minimal ongoing symptoms and functional deficits, which consistently led to high levels of satisfaction; (2) the glass-half-full pathway, characterized by ongoing symptoms and functional limitations, which led to high satisfaction; and (3) the glass-half-empty pathway, also characterized by ongoing symptoms and functional limitations, which led to low satisfaction levels. The latter two pathways were mediated by three core mechanisms (recalibration, reframing valued activities, and reconceptualization) influenced either positively or negatively by (1) a persons' thoughts and feelings such as optimism, self-efficacy, pain catastrophizing, external locus of control; and (2) social and contextual factors such as fulfilment of social roles, therapeutic alliance, lack of family/social support. CONCLUSIONS: This qualitative study suggests that for preoperative patients in whom unrealistically high hopes for complete symptom resolution and restoration of functional capacity persists, it may be appropriate to direct them away from TKA due to the risk of low satisfaction. For postoperative patients troubled by ongoing symptoms or functional limitations, clinicians may improve levels of satisfaction by targeting the three core mechanisms (recalibration, reframing valued activities, and reconceptualization) through addressing modifiable negative thoughts and feelings in interventions such as psychology or psychotherapy; and negative social and contextual factors by promoting a strong therapeutic alliance and engagement in community activities. Given that these factors may be identifiable preoperatively, future research is needed to explore if and how addressing them preoperatively may improve satisfaction post-TKA. LEVEL OF EVIDENCE: Level IV, therapeutic study.
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ItemHow Do People Communicate About Knee Osteoarthritis? A Discourse Analysis(OXFORD UNIV PRESS, 2021-01-27)OBJECTIVE: To explore the ways in which people talk about knee osteoarthritis and how this may influence engagement in physical activity and activity-based interventions as recommended by clinical practice guidelines. DESIGN: A qualitative synthesis using discourse analysis methods. METHODS: Systematic review methods were used to identify qualitative studies exploring the perceptions of people with knee osteoarthritis, their carers, and/or clinicians. Methodological quality was evaluated through the use of the Critical Appraisal Skills Programme. Raw quotes extracted from each study were analyzed with inductive discourse analysis. RESULTS: A search of five electronic databases from inception until August 2019 yielded 778 articles. Sixty-two articles from 56 studies were included, reporting data (1,673 direct quotes) from people with knee osteoarthritis, carers, and clinicians in 16 countries. Two overarching discourses were identified-impairment and participation. The overarching impairment discourse prevailed in all participant groups and study settings. In this discourse, knee osteoarthritis was likened to a machine that inevitably wore down over time and required a doctor to repair. The overarching participatory discourse almost always coexisted alongside an impairment discourse. According to this discourse, a "busy body" was perceived as "healthy," and people could remain active despite knee osteoarthritis. CONCLUSION: The prevailing impairment discourse may potentially discourage people from using knees that have passed their "use-by date" and increase reliance on doctors to repair joint damage. Consistent with recommendations in clinical practice guidelines, a participatory discourse may provide an alternative way of communicating that may encourage people with knee osteoarthritis to continue to engage in physical activity by focusing on what they can do, rather than what they cannot do.
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ItemPlacebo Surgery Controlled Trials Do They Achieve What They Set Out To Do? A Systematic Review(LIPPINCOTT WILLIAMS & WILKINS, 2021-06-01)OBJECTIVE: To explore whether placebo surgery controlled trials achieve what they set out to do by investigating discrepancy between projected and actual design aspects of trials identified through systematic review methods. SUMMARY BACKGROUND: Interest in placebo surgery controlled trials is growing in response to concerns regarding unnecessary surgery and the societal cost of low-value healthcare. As questions about the justifiability of using placebo controls in surgery have been addressed, attention is now being paid to more practical concerns. METHODS: Six databases were searched from inception - May 2020 (MEDLINE, Embase, Emcare, APA PsycInfo, CINAHL, Cochrane Library). Placebo surgery controlled trials with a published protocol were included. Three authors extracted "projected" design aspects from protocols and "actual" design aspects from main findings papers. Absolute and relative difference between projected and actual design aspects were presented for each trial. Trials were grouped according to whether they met their target sample size ("completed") and were concluded in a timely fashion. Pairs of authors assessed risk of bias. RESULTS: Of 24 trials with data available to analyse; 3 were completed and concluded within target timeframe; 10 were completed and concluded outside the target timeline; 4 were completed without clear target timeframes; 2 were incomplete and concluded within the target framework; 5 were incomplete and concluded outside the target timeline. Trials which reached the recruitment target underestimated trial duration by 88% and number of recruitment sites by 87%. CONCLUSIONS: Trialists need to factor additional time and sites into future placebo surgery controlled trials. A robust reporting framework of projected and actual trial design is imperative for trialists to learn from their predecessors. REVIEW REGISTRATION: PROSPERO (CRD42019133296).
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ItemFactors Underlying Patient and Surgeon Willingness to Participate in a Placebo Surgery Controlled trial(Ovid Technologies (Wolters Kluwer Health), 2021)